Device recall
Z-0583-2022: LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R)…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0583-2022 |
|---|---|
| Recall event | 89391 |
| Product | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorganisms are 3 passages or… |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 7, 2022 |
| 510(k) numbers | K861022 |
| FEI number | 2150138 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database